Example 7: Study or Project Template Domain

Develop standard definitions for use in all studies, validate them, and put them in one or more Domains of standard definitions. Create a Study Template Domain with at least one Application Area and copy into it the standard definitions that you know need to be modified for each study. Create a Work Area in the Application Area that contains instances of the definitions in the Study Domain and also instances of definitions in the Standard Domain that do not need modification. In the Work Area, map all executables to Table instances as necessary.

When you begin a new study, copy the entire Study Template Domain, including its Application Areas Work Areas. The object instances in the copied Work Area point to the correct definitions, either in the copied Application Area or in the original Domain. All mappings remain intact.

Through the instances in the copied Work Area, modify the definitions in the Application Area as necessary for the new study.

This model works with Example 1: Project Domain with Reporting on Separately Stored Study Data. You could work out a similar process for the entire Domain, or for the Domain in Example 2: Project Domain with Reporting on Pooled Data.